Orthopedic surgical guide

ABSTRACT

A system for establishing an intramedullary path includes a body sized and configured to be received within a resected bone space. The body defines a first aperture that extends through the body and is sized and configured to receive a surgical tool therethrough. A first bone engaging structure extends from the body in a first direction and includes a first surface that is complementary to a surface topography of a first bone. When the first surface of the bone engaging structure engages the surface topography of the first bone to which the first surface is complementary, an axis defined by the first aperture is substantially collinear with a mechanical axis of the first bone.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/711,307, which was filed on Feb. 24, 2010 claiming priorityto U.S. Provisional Patent Application No. 61/154,845 filed on Feb. 24,2009, and claims priority to U.S. Provisional Patent Application No.61/425,054 filed on Dec. 20, 2010 and to U.S. Provisional PatentApplication No. 61/482,657 filed on May 5, 2011, the entireties of whichare herein incorporated by reference.

FIELD OF DISCLOSURE

The disclosed system and method generally relate to surgical guides.More specifically, the disclosed system and method relate to surgicalguides for orthopedic procedures involving an ankle.

BACKGROUND

Total joint replacement prostheses typically include a speciallydesigned jig or fixture to enable a surgeon to make accurate and precisebone resections in and around the joint being prepared to accept theprosthesis. The ultimate goal with any total joint prosthesis is toapproximate the function and structure of the natural, healthystructures that the prosthesis is replacing. Should the prosthesis notbe properly attached to the joint, i.e., an ankle or knee, themisalignment could result in discomfort to the patient, gait problems,or degradation of the prosthesis.

Many surgical procedures employ the use of intra-operative fluoroscopyto check the alignment of the intramedullary cavities that are preparedto receive the joint replacement prosthesis. However, the use ofintra-operative fluoroscopy in the operating room has several drawbacks.One such drawback is that the use of fluoroscopy to check the alignmentof intramedullary cavities formed during surgery increases the overalllength of the surgical procedure as time is taken to acquire andevaluate the fluoroscopic images. Long surgery times lead to increasedtourniquet time forth patient and therefore may increase recovery time.

Another drawback of fluoroscopy is exposing the patient and others inthe operating room to the ionized radiation. For example, the U.S. Foodand Drug Administration (“FDA”) has issued several articles and publichealth advisories concerning the use of the fluoroscopy during surgicalprocedures. Consequently, even though steps are taken to protect thepatient and other from the ionized radiation, it is virtually impossibleto eliminate all risk associated with the ionized radiation.

SUMMARY

A system for establishing an intramedullary path is disclosed thatincludes a body sized and configured to be received within a resectedbone space. The body defines a first aperture that extends through thebody and is sized and configured to receive a surgical tooltherethrough. A first bone engaging structure extends from the body in afirst direction and includes a first surface that is complementary to asurface topography of a first bone. When the first surface of the boneengaging structure engages the surface topography of the first bone towhich the first surface is complementary, an axis defined by the firstaperture is substantially collinear with a mechanical axis of the firstbone.

Also disclosed is a system for establishing an intramedullary path thatincludes a drill guide mount having a body sized and configured to bereceived within a resected bone space. The body defines a first aperturethat extends through the body. A first bone engaging structure extendsfrom the body in a first direction and includes a first surface that iscomplementary to a surface topography of a first bone. A drill guide issized and configured to be received within the first aperture defined bythe body of the drill guide mount. The drill guide defines a secondaperture sized and configured to receive the surgical tool therethrough.When the first surface of the bone engaging structure engages thesurface topography of the bone to which the first surface iscomplementary, an axis defined by the second aperture is substantiallycollinear with a mechanical axis of the first bone.

A method is also disclosed that includes inserting a drill guide into anaperture defined by a drill guide mount. The drill guide mount includesa first bone engaging structure extending from a body of the drill guidemount in a first direction and having a first surface that iscomplementary to a surface topography of a first bone. The drill guidemount and the drill guide disposed within the first aperture of thedrill guide mount are inserted into a resected bone space such that thefirst surface of the bone engaging structure correspondingly engages thefirst bone. A surgical tool is extended through a second aperturedefined by the drill guide to establish an intramedullary channel withinthe first bone that is substantially collinear with a mechanical axis ofthe first bone.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will bemore fully disclosed in, or rendered obvious by, the following detaileddescription of the preferred embodiment of the invention, which is to beconsidered together with the accompanying drawings wherein like numbersrefer to like parts and further wherein:

FIG. 1 illustrates the bones of a human foot and ankle;

FIGS. 2A and 2B are schematic representations of a scanned image of ahuman foot and ankle joint;

FIG. 3 is a perspective view of tibial and talar resection guideslocated upon portions of a tibia and a talus;

FIG. 4 is an exploded perspective view of a tibial cutting guide mountand tibial resection guide;

FIG. 5 is a perspective view of a tibial cutting guide disposed within atibial cutting guide mount located on an inferior portion of a tibia;

FIG. 6 is a front elevational view of a tibial cutting guide disposedwithin a tibial cutting guide mount located on an inferior portion of atibia;

FIG. 7 is a side elevational view of a tibial cutting guide disposedwithin a tibial cutting guide mount located on an inferior portion of atibia during resection of the tibia;

FIG. 8 is a schematic representation of a resected tibia followingapplication and use of the tibial cutting guide and tibial cutting guidemount;

FIG. 9 is a perspective view of a talar cutting guide disposed within atalar cutting guide mount;

FIG. 10 is an exploded perspective view of the talar cutting guide mountand the talar cutting guide illustrated in FIG. 9;

FIG. 11 is a perspective view of the talar cutting guide disposed withinthe talar cutting guide mount located on a superior portion of a talus;

FIG. 12 is a front elevational view of the talar cutting guide disposedwithin the talar cutting guide mount located on a superior portion of atalus;

FIG. 13 is a side perspective view of the talar cutting guide disposedwithin the talar cutting guide mount located on a superior portion of atalus during resection of the talus;

FIG. 14 is a schematic representation of a resected talus followingapplication and use of the talar cutting guide and talar cutting guidemount;

FIG. 15 is a schematic representation of a resected joint spacefollowing application and use of the talar and tibial cutting guidemounts and cutting guides;

FIG. 16 is a perspective view of one example of a custom tibial drillguide mount;

FIG. 17 is a front elevational view of the tibial drill guide mountillustrated in FIG. 16;

FIG. 18 is a rear elevation view of the tibial drill guide mountillustrated in FIG. 16;

FIG. 19 is a bottom elevational view of the tibial drill guide mountillustrated in FIG. 16;

FIG. 20 is a top elevational view of the tibial drill guide mountillustrated in FIG. 16;

FIG. 21 is a perspective view of one example of a tibial drill guide;

FIG. 22 is a side elevational view of the tibial drill guide illustratedin FIG. 21;

FIG. 23 is a top elevational view of the tibial drill guide illustratedin FIG. 21;

FIG. 24 is an exploded perspective view of the tibial drill guide mountand the tibial drill guide;

FIG. 25A is a side elevational view of the tibial drill guide disposedwithin the tibial drill guide mount being inserted into resected jointspace;

FIG. 25B is a perspective view of the assemblage of the tibial drillguide mount and tibial drill guide disposed within the resected jointspace;

FIG. 25C is a perspective view of the assembly of the tibial drill guidemount and tibial drill guide disposed and pinned within the resectedjoint space;

FIG. 26 is a perspective view of one example of an alignment tool;

FIG. 27 is an exploded perspective view of the alignment toolillustrated in FIG. 26;

FIGS. 28A and 28B illustrate the relative movement permitted betweeneach of the components of the alignment tool illustrated in FIG. 26;

FIG. 29 is a perspective view of one example of an adapter bar forcoupling the assemblage of the tibial drill guide mount and tibial drillguide to the alignment tool;

FIG. 30 is a perspective view of the adapter bar coupled to theassemblage of the tibial drill guide mount and tibial drill guide and tothe alignment tool;

FIG. 31 is a top isometric view of another example of an alignmenttool/foot holder assembly for use with a tibial drill guide mount andtibial drill guide;

FIG. 32 is a bottom isometric view of the alignment tool/foot holderassembly illustrated in FIG. 31;

FIG. 33 is an elevational front view of the alignment tool/foot holderassembly illustrated in FIG. 31;

FIG. 34 is an elevational side view of the alignment tool/foot holderassembly illustrated in FIG. 31;

FIG. 35 is a top isometric view of another example of an alignmenttool/foot holder assembly for use with the tibial drill guide mount andtibial drill guide;

FIG. 36 is a top elevational view of the alignment tool/foot holderassembly illustrated in FIG. 35;

FIG. 37 is an elevational front view of the alignment tool/foot holderassembly illustrated in FIG. 35;

FIG. 38 is an elevational side view of the alignment tool/foot holderassembly illustrated in FIG. 35;

FIG. 39 is a perspective view of another example of a tibial cuttingguide mount;

FIG. 40 is a front side elevational view of the tibial cutting guidemount illustrated in FIG. 39;

FIG. 41 is a side elevational view of the tibial cutting guide mountillustrated in FIG. 39;

FIG. 42 is a top side view of the tibial cutting guide mount illustratedin FIG. 39;

FIG. 43 is a bottom side view of the tibial cutting guide mountillustrated in FIG. 39;

FIG. 44 is a perspective view of a tibial drill guide cartridge for usewith the tibial drill guide mount illustrated in FIG. 39;

FIG. 45 is a front end view of the tibial drill guide cartridgeillustrated in FIG. 44;

FIG. 46 is a bottom side plan view of the tibial drill guide cartridgeillustrated in FIG. 44;

FIG. 47 is a side view of the tibial drill guide cartridge illustratedin FIG. 44;

FIG. 48 is an exploded perspective view of a mounting plate and dowelpins configured to for use with the tibial drill guide mount illustratedin FIG. 39;

FIG. 49 is a partially exploded perspective view of a mounting plate anddowel pins configured to for use with the tibial drill guide mountillustrated in FIG. 39;

FIG. 50 is a partially exploded perspective view of a mounting plate,dowel pins, and tibial drill guide mount configured to receive a tibialdrill guide cartridge in accordance with FIG. 44;

FIG. 51 is a perspective view of the tibial drill guide mount, tibialdrill guide cartridge, dowel pins, and mounting plate assembledtogether;

FIG. 52 is a side view of the assembly illustrated in FIG. 51;

FIG. 53 is a top side plan view of the assembly illustrated in FIG. 51;

FIG. 54 is a bottom side plan view of the assembly illustrated in FIG.51,

FIG. 55 is a perspective view of a foot holder assembly for use with theassembly illustrated in FIG. 51;

FIG. 56 is a perspective view of a pivoting arrangement used to securethe assembly illustrated in FIG. 51 to the foot holder assembly;

FIG. 57 is a top side plan view of the foot holder assembly illustratedin FIG. 55;

FIG. 58 is a side view of the foot holder assembly illustrated in FIG.55;

FIG. 59 is an opposite side view of the foot holder assembly illustratedin FIG. 55;

FIG. 60 is a rear end view of the foot holder assembly illustrated inFIG. 55;

FIG. 61 is a front end view of the foot holder assembly illustrated inFIG. 55;

FIG. 62 is a perspective view of a drill being extended through the footholder assembly and tibial drill guide.

DETAILED DESCRIPTION

This description of preferred embodiments is intended to be read inconnection with the accompanying drawings, which are to be consideredpart of the entire written description. The drawing figures are notnecessarily to scale and certain features may be shown exaggerated inscale or in somewhat schematic form in the interest of clarity andconciseness. In the description, relative terms such as “horizontal,”“vertical,” “up,” “down,” “top” and “bottom” as well as derivativesthereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should beconstrued to refer to the orientation as then described or as shown inthe drawing figure under discussion. These relative terms are forconvenience of description and normally are not intended to require aparticular orientation. Terms including “inwardly” versus “outwardly,”“longitudinal” versus “lateral” and the like are to be interpretedrelative to one another or relative to an axis of elongation, or an axisor center of rotation, as appropriate. Terms concerning attachments,coupling and the like, such as “connected” and “interconnected,” referto a relationship wherein structures are secured or attached to oneanother either directly or indirectly through intervening structures, aswell as both movable or rigid attachments or relationships, unlessexpressly described otherwise. When only a single machine isillustrated, the term “machine” shall also be taken to include anycollection of machines that individually or jointly execute a set (ormultiple sets) of instructions to perform any one or more of themethodologies discussed herein. The term “operatively connected” is suchan attachment, coupling or connection that allows the pertinentstructures to operate as intended by virtue of that relationship. In theclaims, means-plus-function clauses, if used, are intended to cover thestructures described, suggested, or rendered obvious by the writtendescription or drawings for performing the recited function, includingnot only structural equivalents but also equivalent structures.

The disclosed systems and methods advantageously utilize custommanufactured surgical instruments, guides, and/or fixtures that arebased upon a patient's anatomy to reduce the use of fluoroscopy during asurgical procedure. In some instances, the use of fluoroscopy during asurgical procedure may be eliminated altogether. The custom instruments,guides, and/or fixtures are created by imaging a patient's anatomy witha computer tomography scanner (“CT”), a magnetic resonance imagingmachine (“MRI”), or like medical imaging technology prior to surgery andutilizing these images to create patient-specific instruments, guides,and/or fixtures.

Although the following description of the custom patient-specificinstruments are described with respect to a foot 10 and ankle 12 (FIG.1), one skilled in the art will understand that the systems and methodsmay be utilized in connection with other joints including, but notlimited to, knees, hips, shoulders, and the like. As shown in FIG. 1, atypical human foot 10 includes an ankle joint 12 formed between a talus14, which is disposed on a calcaneus 20, and a tibia 16 and fibula 18.

A CT or MRI scanned image or series of images may be taken of apatient's ankle 12 (or other joint) and then converted from, e.g., aDICOM image format, to a solid computer model of the ankle including thecalcaneus, talus, tibia, navicular, and fibula to determine implantalignment, type, and sizing using specialized modeling methods that areoften embodied in computer software. Computer generated solid modelsthat are derived from the data of the CT or MRI scan image will ofteninclude precise and accurate information regarding the surface contourssurrounding the structures that have been imaged, e.g., the surfacetopography of the bones or contour of fascia that have been imaged. Itwill be understood that by surface topography it is meant the location,shape, size and distribution of surface features such as concavities andprominences or the like.

The methods disclosed in U.S. Pat. No. 5,768,134, issued to Swaelens etal., which is incorporated by reference herein in its entirety, havebeen found to yield adequate conversions of data of CT or MRI scanimages to solid computer models. In some embodiments, images are made ofa foot 10, i.e., the calcaneus 20, talus 14, tibia 16, and fibula 18 ofa patient using a CT or MRI machine, or other digital image capturingand processing unit as is understood by one skilled in the art. Theimage data is processed in a processing unit, after which a model 50 isgenerated using the processed digitized image data as illustrated inFIGS. 2A and 2B.

Interactive processing and preparation of the digitized image data isperformed, which includes the manipulation and introduction ofadditional extrinsic digital information, such as, predefined referencelocations 52 for component positioning and alignment so that adjustmentsto the surgical site 54, that will require resection during surgery, maybe planned and mapped onto computer model 50 (FIGS. 2A and 2B). Afterthe interactive processing of the digitized image data, it is possibleto go back to original CAD data to obtain a higher resolution digitalrepresentation of the patient specific surgical instruments, prostheses,guides, or fixtures so as to add that digital representation to thepatient's image data model.

FIG. 3 illustrates a pair of custom cutting guides for an anklereplacement surgery including a tibial resection guide mount 100 and atalar resection guide mount 102, which are formed and mounted to thepatient's lower tibia 16 a and upper talus 14 a. A custom tibial drillguide mount 200 (FIGS. 16-20) is also formed and configured to bereceived within ankle space created by using the custom tibial and talarresection guide mounts 100, 102. Although custom cutting guides aredescribed for preparing a patient's talus, tibia, and femur, one skilledin the art will understand that other cutting guides may be implementedand that custom guides may be created for other joints including, butnot limited to, the knee, hip, shoulder, or other joint.

Tibial resection guide mount 100 illustrated in FIG. 3 is formed from aresilient polymer material of the type that is suitable for use inconnection with stereo lithography, selective laser sintering, or likemanufacturing equipment. Resection guide mount 100 includes a unitarybody including a cruciform tibial yolk 104 projecting upwardly from abase 106 that further defines a guide receptacle recess 108 as best seenin FIG. 4. Cruciform yolk 104 includes a pair of spaced apart arms 110,112 that project outwardly from a central post 114. Arms 110, 112 andcentral post 114 each have a conformal bone engaging surface 116 that iscomplementary to the contours of a corresponding portion of thepatient's lower tibia 16 a as illustrated in FIG. 7. Through thepreviously discussed imaging operations, conformal bone engagingsurfaces 116 of arms 110, 112 and central post 114 are configured forcomplementary matching with anatomical surface features of a selectedregion of the patient's natural bone. For tibial resection guide mount100, the selected bone region comprises the lower surfaces of thepatient's tibia 16 a.

As best seen in FIGS. 3-5, a pilot block 118 projects outwardly fromcentral post 114, adjacent to the intersection of arms 110,112. Asupport block 120 (FIG. 4) is located on base 106 in spaced relation topilot block 118. Guide receptacle recess 108 is defined by a pair ofwings 122,124 that extend outwardly from either side of central post 114in opposite directions on base 106, with support block 120 locatedbetween them. Each wing 122, 124 includes a respective pylon 126projecting outwardly from base 106 so as to provide lateral support fortibial resection guide 132 (FIGS. 4 and 5). An elongate slot 128 isdefined transversely in a central portion of base 106 below pilot block118, but above support block 120. Each wing 122, 124 also defines arespective slot 130 that is oriented at an angle relative to centralpost 114. In some embodiments, slots 130 are disposed at anon-perpendicular angle relative to central post 114, although oneskilled in the art will understand that slots 130 may be disposed atperpendicular angles with respect to the direction in which central post114 extends. Slots 128 and 130 are sized and shaped to allow a typicalsurgical saw 60 (FIG. 7) of the type often used for bone resection, topass through from a correspondingly positioned and sized slot inresection guide 132 without contact, or with only incidental contactwith resection guide mount 100.

Referring again to FIG. 4, tibial resection guide 132 includes a pair ofarms 134 that project downwardly and outwardly in diverging angularrelation from the ends of a bridge beam 136. The shape of tibialresection guide 132 is complementary to the shape of guide receptaclerecess 108 as defined by the inwardly facing surfaces of pilot block118, support block 120, and pylons 126. Bridge beam 136 defines anelongate slot 138 that aligns with slot 128 when tibial resection guideis coupled to and supported by resection guide mount 100. Arms 134 eachdefine a respective slot 140 that align with a respective slot 130.

The inwardly facing surfaces 142 of pilot block 118, support block 120,and pylons 126, that together define guide receptacle recess 108, have ashape that is complementary to the outer profile of tibial resectionguide 132. Guide receptacle recess 108 is sized so as to accept tibialresection guide 132 with a “press-fit”. By press-fit it should beunderstood that the inwardly facing surfaces 142 of pilot block 118,support block 120, and pylons 126 are sufficiently resilient to deflector compress elastically so as to store elastic energy when tibialresection guide 132 is pushed into guide receptacle recess 108. Ofcourse, it will also be understood that tibial resection guide 132 willhave an outer peripheral shape that is complementary to thecircumferential shape of guide receptacle recess 108, but slightlylarger in size, for press-fit embodiments. Also, tibial resection guide132 may be retained within guide receptacle recess 108 by onlyfrictional engagement with the inwardly facing surfaces of pilot block118, support block 120, and pylons 126. In some embodiments, tibialresection guide 132 can simply slide into guide receptacle recess 108without operative contact or only incidental engagement with theinwardly facing surfaces of pilot block 118, support block 120, andpylons 126.

Referring now to FIGS. 9 and 10, a talar resection guide mount 102 isformed from a resilient polymer material of the type that is suitablefor use in connection with stereo lithography, selective lasersintering, or the like manufacturing equipment, e.g., a polyamide powderrapid prototype material is suitable for use in connection withselective laser sintering. Talar resection guide mount 102 also includesa conformal bone engaging surface 144 that is complementary to thecontours of a corresponding portion of the patient's upper talus 14 a(FIGS. 11 and 13). Through the previously discussed imaging operations,conformal bone engaging surface 144 of talar resection guide mount 102is configured for complementary matching with anatomical surfacefeatures of a selected region of the patient's natural bone. For talarresection guide mount 102, the selected bone region comprises the outer,upper surfaces of the patient's talus.

Talar resection guide mount 102 comprises a unitary block that defines acentral guide receptacle recess 146 and a pair of through-bores 148(FIG. 10). Guide receptacle recess 146 is defined by the inwardly facingsurfaces 150 of a pair of wings 152, 154 that project outwardly, inopposite directions from a base 156. Each wing 152,154 includes a pylon158 projecting upwardly to support guide housing 160 such that anelongate slot 162 is defined within base 156 and below guide housing 160(FIGS. 10 and 11). Slot 162 is sized and shaped to allow a typicalsurgical saw 60, of the type often used for bone resection, to passthrough from a correspondingly positioned and sized slot 164 in talarresection guide 166 without contact, or with only incidental contactwith talar resection guide locator 102 (FIGS. 11 and 13). An annularwall 168, having a shape that is complementary to the outer profile oftalar resection guide 166, projects outwardly in substantiallyperpendicular relation to a back wall and so as to further defines guidereceptacle recess 146.

Still referring to FIGS. 9 and 10, talar resection guide 166 includes apair of confronting, parallel plates 170, 172 that define elongate slot164 between them, and are joined to one another at their ends by wings174. In this way, the shape of talar resection guide 166 iscomplementary to the shape of guide receptacle recess 146 as defined bythe inwardly facing surfaces 150 of wings 152, 154, base 156, and pylons158. Guide receptacle recess 146 is sized so as to accept talarresection guide 166 with a press-fit. Of course, it will also beunderstood that talar resection guide 166 will have an outer peripheralshape that is complementary to the circumferential shape of guidereceptacle recess 146, but slightly larger in size, for press-fitembodiments. Also, talar resection guide 166 may be retained withinguide receptacle recess 146 by only frictional engagement with theinwardly facing surfaces 150 of wings 152, 154, base 156, and pylons158. In some embodiments, talar resection guide 166 can simply slideinto guide receptacle recess 146 without operative contact or onlyincidental engagement with the inwardly facing surfaces 150 of wings152, 154, base 156, and pylons 158.

Tibial drill guide mount 200 illustrated in FIGS. 16-20 also may befabricated from a resilient polymer material of the type that issuitable for use in connection with stereo lithography, selective lasersintering, or the like manufacturing equipment, e.g., a polyamide powderrepaid prototype material is suitable for use in connection withselective laser sintering. As shown in FIGS. 16-20, tibial drill guidemount 200 includes a somewhat rectangular body 204 that defines anaperture 206 that extends from a top surface 208 of body 204 to a bottomsurface 210 of body 204. Top surface 208 of body 204 may include a pairof chamfers 212 that are sized and configured to be mate against theresected surfaces of the lower tibia 16 a (FIG. 8). Put another way, thetop or upper surface 208 of body 204, including chamfers 212, iscomplementary to the geometry and locations of slots 138 and 140 oftibial resection guide 132.

Front side 214 of body 204 defines one or more blind holes 216. Asillustrated in the embodiment shown in FIG. 17, body 204 may definethree blind holes 216-1, 216-2, and 216-3. In some embodiments, blindholes 216-1 and 216-2 may be reamed holes that are sized and configuredto receive a dowel pin, and blind hole 216-3 may also be a reamed holefor receiving a dowel pin or blind hole 216-3 may be threaded forengaging a screw as described below.

Aperture 206 may have a circular cross sectional area and include ashoulder 218 having a reduced diameter compared to aperture 206 andincludes an anti-rotational feature 220 as best seen in FIG. 20.Anti-rotational feature 220 of shoulder 218 may include one or moreflats or other geometric structure(s) to prevent tibial drill guide 202from rotating with respect to tibial drill guide mount 200 when tibialdrill guide 202 is disposed within aperture 206.

Extending from body 204 of tibial drill guide mount 200 are tibialengagement structure 222 and talar engagement structure 224. The outersurface 226 of tibial engagement structure 222 may have a rectangularshape that is substantially planar, and the internal and substantiallyconformal engagement surface 228 of tibial engagement structure 222 maybe somewhat convex for engaging the tibia 16 of the patient. Tibialengagement structure 222 may define one or more holes 230 for receivinga k-wire or pin as described below.

Talar engagement structure 224 may also include a substantially planarand rectangular outer surface 232. The lower portion 234 of talarengagement structure 224 may be a conformal surface having a geometrythat matches the geometry of the talar bone 14 (FIG. 14). Talarengagement structure 224 may also define one or more holes 236 sized andconfigured to receive a k-wire as described below.

Tibial drill guide 202 illustrated in FIGS. 21-23 is preferablyfabricated from a material having more structural integrity than tibialdrill guide mount 200 to enable drill guide 202 to guide a drill bitwithout being damaged. Examples of materials include, but are notlimited to, metals, ceramics, or the like. Drill guide 202 has acylindrically shaped first portion 238 that is sized and configured tobe received within the portion of aperture 206 that extends through theshoulder or reduced diameter area 218. A second portion 240 of drillguide 202 has a larger cross-sectional diameter than first portion 238and is sized and configured to be received within aperture 206 of tibialdrill guide mount 200. A flat 242, which is best seen in FIGS. 21 and23, is formed along an exterior surface 244 of first portion 238 ofdrill guide 202. The internal surface 248 of second portion 240 oftibial drill guide 202 has a conical shape that intersects andcommunicates with aperture 246 such that a drill or reamer may bereceived through drill guide 202.

As with the digital image models 50 disclosed above, and considering ageneralized digital model of a tibial resection guide mount 100 added tothe patient's lower tibia image data, the anatomic surface features ofthe patient's lower tibia, e.g., the surface topography, may becomplementarily mapped onto each of conformal bone engaging surfaces 116of arms 110, 112, and central post 114, i.e., the surfaces that willengage the bones unique surface topography, of tibial resection guidemount 100. It will be understood that complementary mapping of thedigital images results in localized prominences on the surface of a bonebecoming localized concavities on conformal bone engaging surfaces 116of arms 110, 112, and central post 114 of tibial resection guide mount100, while localized concavities on the surface of a bone becomelocalized prominences on conformal bone engaging surfaces 116 of arms110, 112, and central post 114.

Each of conformal bone engaging surfaces 116 of arms 110, 112, andcentral post 114 of resection guide mount 100 is redefined with acomplementary, substantially mirror image of the anatomic surfacefeatures of a selected region of the patient's lower tibia 16 a. As aconsequence of this complementary bone surface mapping, tibial resectionguide mount 100 releasably “locks” on to the complementary topography ofthe corresponding portion of the patient's natural tibia without theneed for other external or internal guidance fixtures. In other words,the mating of bone surface asperities in their corresponding concavitiesformed in conformal bone engaging surfaces 116 of tibial resection guidemount 100 ensures that little or no relative movement, e.g., slippingsideways, occurs between tibial resection guide mount 100 and the tibialsurface.

A substantially identical mapping is carried out in connection with thedesign of a patient specific talar resection guide mount 102 and tibialdrill guide mount 200. Notably, the mapping for the design of tibialdrill guide mount 200 is performed by extrapolating where the resectionsto the tibia 16 and talus 14 will be made using tibial and talarresection guide mounts 100 and 102 and mapping the tibial drill guidemount 200 onto the extrapolated geometry of the tibia and talus.

A visual presentation of the virtual alignment results between thepatient's lower tibia 16 a and resection guide mount 100, the patient'supper talus 14 a and resection guide mount 102, and the proposedresected area that that is to be created by resecting the talus 14 andtibia utilizing the tibial resection guide mount 100 and the talarresection guide mount 102 are created and forwarded to the surgeon toobtain approval of the results prior to manufacturing. Additionally, thesurgeon may be provided with a visual representation of the virtualalignment results between the proposed resected joint space and tibialdrill guide mount 200 are created and forwarded to the surgeon to obtainapproval of the results prior to manufacturing. Upon receipt of thesurgeon's approval, resection guide mount 100, resection guide mount102, and tibial drill guide mount 200 are manufactured and returned tothe surgeon for use in the surgery.

During a total ankle replacement, for example, the surgeon makes ananterior incision to gain initial access to the ankle joint. The surgeonorients tibia resection guide mount 100 on lower tibia 16 a until theconformal bone engaging surfaces 116 of arms 110, 112 and central post114 of tibial resection guide mount 100 securely engage one another soas to releasably “interlock” with the topography of the exposed surfaceof lower tibia 16 a as best seen in FIGS. 5-7. With tibial resectionguide mount 100 locked onto the patient's lower tibia 16 a, a surgeonpress-fits an appropriately configured distal resection guide 132 inguide receptacle recess 108 of tibial resection guide mount 100. Thisresults in the resection guide mount 100 being sandwiched between theresection guide 132 and the patient's bone tibia 16 a (FIGS. 5 and 6).With the resection guide mount 100 accurately positioned with respect tothe selected bone region and resection guide mount 100 constructappropriately secured to the patient's bone by virtue of the mating ofbone surface asperities in their corresponding concavities formed inconformal bone engaging surfaces 116, the surgeon uses a conventionalsurgical blade 60 and the resection slots 128 and 130 of resection guide132 to resect the patient's bone 16 (FIGS. 7 and 8).

In a similar fashion, when talar resection guide mount 102 is added tothe patient's talar image data, the anatomic surface features of thepatient's upper talus, e.g., the surface topography, may becomplementarily mapped onto conformal bone engaging surface 144. It willagain be understood that complementary mapping of the digital imagesresults in localized prominences on the surface of a bone becominglocalized concavities on conformal bone engaging surface 144, whilelocalized concavities on the surface of a bone become localizedprominences on conformal bone engaging surface 144. In this way,conformal bone engaging surface 144 is redefined with a complementary,substantially mirror image of the anatomic surface features of aselected region of the patient's lower tibia. As a consequence of thiscomplementary bone surface mapping, talar resection guide mount 102releasably “locks” on to the complementary topography of thecorresponding portion of the patient's natural talus without the needfor other external or internal guidance fixtures.

To continue the total ankle replacement the surgeon orients resectionguide mount 102 on upper talus 14 a until conformal bone engagingsurface 144 of resection guide mount 102 “locks” to the topography ofthe exposed surface of upper talus 14 a (FIG. 11). With resection guidemount 102 locked onto the patient's upper talus, a surgeon press-fits anappropriately configured distal resection guide 166 in guide receptaclerecess 146 of talar resection guide mount 102. This results in resectionguide mount 102 being sandwiched between resection guide 166 and thepatient's bone 14 (FIGS. 12 and 13). With the resection guide mount 102accurately positioned with respect to the selected bone region andresection guide 166 and guide mount 102 appropriately constructed andsecured to the patient's bone, by virtue of the mating of bone surfaceasperities in their corresponding concavities formed in conformal boneengaging surfaces 144, the surgeon uses a conventional surgical blade 60and the resection slot 164 of resection guide 166 to resect thepatient's bone 14 (FIGS. 13 and 14).

Once the tibia 16 and talus 14 have been resected, tibial drill guidemount 200 and tibial drill guide 202 are coupled together and installedinto resected joint space 22 (FIG. 15). Tibial drill guide mount 200 andtibial drill guide 202 are coupled together by inserting first portion238 of tibial drill guide 202 into aperture 206 defined by body 204 oftibial drill guide mount 200 (FIG. 24). Flat 242 formed on the firstportion 238 of tibial drill guide 202 is aligned with anti-rotationfeature 220 of shoulder 218 such that tibial drill guide 202 slides intoaperture 206 until a lower surface 250 of second portion 240 of drillguide 202 contacts and abuts shoulder 218 of tibial drill guide mount200.

Body 204 of tibial drill guide mount 200, in which tibial drill guide202 is disposed, is inserted into resected joint space 22 in an anteriorposterior direction with chamfers 212 sliding along resected areas oftibia 16 formed by utilizing slots 140 of tibial resection guide 132 asbest seen in FIGS. 25A and 25B. The assemblage of tibial drill guidemount 200 and tibial drill guide 202 are slid into resected joint space22 until talar engagement structure contacts talus 14. A surgeon maymove tibial guide mount 200 within resected joint space until conformalsurface 228 is appropriately secured to the patient's bone by virtue ofthe mating of bone surface asperities in their corresponding concavitiesformed in conformal bone engaging surface 228. Once properly located,k-wires 62 may be inserted into holes 230 and/or holes 236, respectivelydefined by tibial engagement structure 222 and talar engagementstructure 224, to secure the assemblage of the tibial drill guide mount200 and tibial drill guide 202 to the patient's tibia 16 and talus 14 asillustrated in FIG. 25C.

With tibial drill guide mount 200 and tibial drill guide 202 securedwithin resected joint space 22, the patient's leg is inserted into afoot holder and alignment tool 300. FIGS. 26-28B illustrate one exampleof an alignment tool 300, which serves the task of supporting the anklejoint during a prosthesis installation procedure. Alignment tool 300includes a foot holder assembly 302 and a leg rest 304. Foot holderassembly 302 includes a foot rest 306, to which the foot is secured by afoot clamp 310 and heel clamps 308 during an prosthesis installationprocedure. The calf of the leg is suitably secured to the leg rest 304once the ankle joint has been resected and tibial drill guide mount 200and tibial drill guide 200 have been installed. Together, foot holderassembly 302 and leg rest 304 hold the foot and ankle relative to theleg during an installation procedure.

As shown in FIG. 26, foot holder assembly 302 is sized and configuredfor pivoting, under control of the physician, from a vertical or uprightcondition (shown in solid lines in FIG. 26) toward a more horizontal ortilted condition (shown in phantom lines in FIG. 26). In the uprightcondition, assembly 302 serves to hold the ankle joint in a desiredorientation with respect to the natural anterior-to-posterior andmedial-to-lateral axes.

As best seen in FIG. 27, foot holder assembly 302 includes a back plate312 and a mid-plate 314, which is sandwiched between foot rest 306 andback plate 312. Mid-plate 314 is coupled to the foot rest 306 by slidingdovetail couplings 316 for up-and-down (i.e., vertical) movementrelative to foot rest 306. A pair of oppositely spaced alignment rods318 is carried by the mid-plate 314.

Alignment rods 318 are disposed in the same horizontal plane and extendfrom mid-plate 314 through vertically elongated slots 320 defined byfoot rest 306 such that rods 318 are disposed on opposite sides of thetibia in the medial-to-lateral plane when a foot is supported by footholder assembly 302. Vertical movement of mid-plate 314 moves alignmentrods 318 up-and-down in unison within slots 320 on opposite sides of thefoot rest 306 (FIG. 28A).

Back plate 312 is coupled to mid-plate 314 by sliding dovetail couplings322 for side-to-side (i.e., horizontal) movement relative to foot rest306 as illustrated in FIG. 28B. Back plate 312 also carries a bushing324, which extends through openings 326 defined by mid-plate 314 andfoot rest 306 and terminates at or near the plane of the foot rest 306against which the bottom of the foot contacts. The center of the bushing324 coincides with the intersection of the horizontal plane of the rods318.

An adapter bar 400 for coupling tibial drill guide mount 200 toalignment tool 300 is illustrated in FIG. 29. Adapter bar 400 includesan elongate body 402 linearly extending from a first end 404 to a secondend 406. Each of the ends 404, 406 includes a respective extension 408,410 that extends from elongate body 402 at an angle. In someembodiments, extensions 408 and 410 orthogonally extend from elongatebody 402, although one skilled in the art will understand thatextensions 408 and 410 may diverge from elongate body 402 at otherangles. In some embodiments, elongate body 402 may not have a linearshape, but may have a curved or arced shape as will be understood by oneskilled in the art.

Each extension 408 and 410 defines a respective hole 412, 414 that issized and configured to slidably receive alignment rods 318 that extendfrom alignment tool 300. Elongate body 402 defines one or more holes416-1, 416-2, and 416-3 (collectively referred to as “holes 416”) forcoupling to adapter bar 400 to tibial drill guide mount 200. In someembodiments, the one or more holes 416 align with one or more holes 216defined by body 204 of tibial drill guide mount 200 such that a pin orother device for maintaining the alignment and engagement of adapter bar400 and tibial drill guide mount 200. For example, holes 216-1 and 216-2of tibial drill guide mount 200 align with holes 416-1 and 416-2 ofadapter bar 400, and hole 216-3 of drill guide mount 200 aligns withhole 416-3 of adapter bar 400. Dowel pins 70 (shown in FIG. 25C) may beinserted into holes 216-1 and 416-1 as well as into holes 216-2 and416-2 to align tibial drill guide mount 200 with adapter bar 400 in boththe horizontal and vertical directions (e.g., in the x- andy-directions), and a screw (not shown) may be inserted through hole416-3 into threaded hole 216-3 to secure tibial drill guide mount 200 toadapter bar at the proper height or depth (e.g., in the z-direction).

With tibial drill guide mount 200 and tibial drill guide 202 disposedwithin the resected ankle space 22, the foot and lower leg are placed infoot rest 306 and leg rest 304 (FIG. 30). The physician estimates theankle's axis of dorsi-plantar rotation and visually aligns the ankle tothe axis of rotation of the alignment tool 300. Foot rest 306 isadjusted to rotate the foot so that the big toe is essentially pointingin a vertical direction with respect to the leg that extends in ahorizontal direction. The forefoot and heel are secured to foot rest 306with clamps 308 and 310. Leg rest 304 is adjusted to the calf so thatthe tibia 16 is approximately parallel to the floor. The foot and calfare desirably aligned so that the anterior-posterior (“A-P”) line of thetalus's trochlea is essentially vertical.

Adapter bar 400 is coupled to alignment tool 300 by aligning holes 412and 414 that are respectively defined by extensions 408 and 410 withalignment rods 318 of alignment tool 300. Adapter bar 400 is then slidalong alignment rods 318 until holes 416 of adapter bar align with holes216 defined by body 204 of tibial drill guide 200 (FIG. 30). Asdescribed above, dowel pins 70 are inserted into holes 416-1 and 416-2of adapter bar 400 and holes 216-1 and 216-2 of tibial drill guide mount200. With dowels 70 disposed within holes 216-1, 216-2, 416-1, and416-2, tibial drill guide mount 200 is properly aligned with alignmenttool 300 in the medial lateral (e.g., x-direction) and superior-inferior(e.g., y-direction) directions. A screw is inserted through hole 416-3into threaded hole 216-3, which secures tibial drill guide mount 200 toadapter bar 400 and provides proper alignment in the anterior-posteriordirection (e.g., the z-direction).

With the patient's foot disposed within alignment tool 300, bushing 324on back plate 312 establishes alignment with the mechanical axis oftibia 16 and alignment of rods 318. Thus, after using adapter bar 400 toalign tibial drill guide mount 200 with alignment tool 300 as describedabove, in line drilling of the center of the ankle and tibia forintroduction of a bottom foot cannula is made possible without the useof fluoroscopy since aperture 246 of tibial drill guide 202 disposedwithin tibial drill guide mount 200 is aligned with an axis defined bybushing 324. Such arrangement enables an intramedullary channel to beformed that is substantially collinear with a mechanical axis defined bythe tibia.

Various minimally invasive surgical techniques may be used to introducea bottom foot cannula into the calcaneus 20, talus 14, and tibia 16. Inone representative embodiment, bushing 324 is temporarily separated fromthe back plate 312 (e.g., by unscrewing) to provide access to the bottomof the foot. The physician uses a scalpel to make an initial incision inthe bottom of the foot and replaces bushing 324. A cannulated trocarloaded with a k-wire (not shown) can be inserted through bushing 324,into the bottom of the foot, until the calcaneus 20 is contacted and thek-wire is firmly set within the calcaneus 20. The trocar can then beremoved, and the k-wire lightly tapped further into the calcaneus 20. Ina representative embodiment, the bushing 324 measures 6 mm in diameter,and the cannulated trocar can be 6 mm loaded with a 2.4 mm k-wire. Thephysician can now operate a cannulated first reamer (e.g., 6 mm) (notshown) over the k-wire up into the calcaneus 20 and talus 14. The firstreamer opens an access path for insertion of a bottom foot cannula.

After withdrawing the first reamer and bushing 324, the physician theninserts a bottom foot cannula 64 as shown in FIG. 30. With the bottomfoot cannula 64 in place, a second reamer 66 (e.g., 5 mm) can beoperated through the cannula 64 to drill approximately another 100 mmthrough the talus 14 and up into the tibia 16 to establish anintramedullary guide path through the calcaneus 20 and talus 14 leadinginto the tibia 16 (FIG. 30). As second reamer 66 is advanced towardstibia 16, the tip 68 of reamer 66 is guided by the conical interiorsurface 248 of tibial drill guide 204, which is aligned with bushing 324of alignment tool 300.

Once an intramedullary channel through the calcaneus 20, talus 14, andtibia 16 has been established, adapter bar 400 is decoupled from drillguide mount 200 and alignment rods 318. Drill guide mount 200 is removedfrom resected joint space 22 to expose the resected joint space to thesurgeon.

With the resected ankle joint space 22 exposed to the surgeon, an ankleprosthesis is then installed. In one example, the ankle prosthesisincludes a stem that may extend from the bottom of the calcaneus up tothe top of the talus (i.e., a talo-calcaneal stem), although in someembodiment the stem is completely disposed within the talus (i.e., atalar stem). A convex dome is coupled to the stem and provides anarticulating joint surface. A tibial stem may be monolithic or include aplurality of segments that may be coupled together in situ. A tibialplatform couples to the tibial stem and either includes or is coupled toa convex joint surface for articulating with the articulating jointsurface coupled to the talar/talo-calcaneal stem. Examples of such ankleprosthesis and methods of installing such prosthesis are disclosed inU.S. Pat. No. 7,534,246 issued to Reiley et al., the entirety of whichis herein incorporated by reference.

The disclosed tibial drill guide mount 200 and drill guide 202 may beused with a variety of alternative alignment tools. For example, FIGS.31-34 illustrate another example of an alignment tool in the form of afoot holder assembly 500 to which tibial drill guide mount 200 may bedirectly coupled. As shown in FIGS. 31 and 32, foot holder assembly 500includes a base plate 502 defining a plurality of slots 504 and 506 andan aperture 503.

Slots 504 are sized and configured to slidably receive a pair of heelclamps 508, and slots 506 are sized and configured to slidably receive apair of forefoot clamps or guides 510. Heel clamps 508 and forefootclamps 510 cooperate to maintain a foot of a patient in a desiredposition with respect to base plate 502 by utilizing a locking mechanismsuch as, for example, a set screw or other locking device, to fix theposition of heel clamps 508 and forefoot clamps 510 to base plate 502.The respective foot engaging surfaces 512 and 514 of heel clamps 508 andforefoot clamps 510 may have a shape that complements the medial andlateral shape of a human foot.

Extending from base plate 502 are a pair of alignment rods 516 that arearranged on base plate 502 such that one alignment rod is disposed on amedial side of a patient's foot and the other alignment rod is disposedon a lateral side of a patient's foot. A coupling bar 518 is sized andconfigured to slidably engage alignment rods 516 as best seen in FIGS.32 and 34. Coupling bar 518 includes a pair of spaced apart legs 520that define channels 522 (FIG. 32) in which alignment rods 516 areslidably received. One or both of legs 520 include a clamp or otherlocking mechanism 524 for increasing the friction between coupling bar518 and alignment rods 516 in order to releasably lock coupling bar 518at a certain position along the length of alignment rods 516.

Medial-lateral cross bar 526 couples together legs 520 of coupling bar518. Extending from medial-lateral cross bar 526 is mount couplingmember 528. Mount coupling member 528 includes one or more holes 530-1,530-2, and 530-3 (collectively referred to as “holes 530”) that aresized and configured to align with holes 216 defined by tibial drillguide mount 200.

A peg 532 (FIG. 33) extends from medial-lateral cross bar 526 forcoupling shin engaging member 534 via slot 536 defined by shin engagingmember 534. Shin engaging member 534 includes a shelf 538 having aconcave surface 540 for abutting a shin of a patient. A nut or otherlocking mechanism (not shown) for engaging peg 532, which may bethreaded, may be used to fix the position of shelf 538 relative tomedial-lateral cross bar 526.

The use of foot holder assembly 500 in connection with the assemblage oftibial drill guide mount 200 and tibial drill guide 202 is similar tothe use of alignment tool 300 described above. For example, once theassembly of tibial drill guide mount 200 and tibial drill guide 202 aredisposed within resected joint space 22, the heel of the patient's footis placed between heel clamps 508 and the patient's forefoot is placedbetween forefoot clamps 510. The locking mechanisms of heel and forefootclamps 508 and 510 may be engaged to initially set positions of heel andforefoot clamps 508 and 510 relative to base plate 502.

Holes 530 of coupling member 528 are aligned with holes 216 defined bytibial drill guide mount 200 by sliding legs 520 of coupling bar 518along alignment rods 516. Dowel pins 70 and/or a threaded screw (notshown) may be used to couple holes 530 of coupling member 528 to holes216 of tibial drill guide mount 200. The surgeon may check to ensurethat the patient's foot is firmly against base plate 502 and then engageclamps 524 such that coupling bar 518 is fixed to alignment rods 516.

Shin engaging member 534 is adjusted until concave surface 540 contactsthe patient's shin. The adjustment of shin engaging member 534 is guidedby the engagement between slot 536 and peg 532. With shin engagingmember 534 in the desired position, the nut or other locking mechanism(not shown) locks shin engagement member 534 in place. The surgeon maymake final adjustments to the heel and forefoot clamps 508 and 510 andthen create the intramedullary channel as described above.

Another example of an alignment tool 600 for use with tibial drill guidemount 200 and tibial drill guide 202 is illustrated in FIGS. 35-38. Asshown in FIG. 35, alignment tool 600 includes a base plate 602comprising a plurality of bars 602 a, 602 b, and 602 c. Although threebars 602 a, 602 b, and 602 c are illustrated, one skilled in the artwill understand that fewer or more bars may be implemented. Bar 602 bdefines a hole 603 sized and configured to receive a surgical tool, suchas, for example, a cannulated drill. Additional elements including, butnot limited to, heel clamps and/or forefoot clamps (not shown) may becoupled to the bars 602 a, 602 b, and 602 c of base plate 602 for aidingin the positioning of a patient's foot with respect to hole 603.

Extending from base plate 602 is a pair of spaced apart alignment rods604. One of alignment rods 604 may be disposed on a medial side of apatient's leg, and the other alignment rod 604 disposed on a lateralside of the patient's leg. Alignment rods 604, like alignment rods 318of alignment tool 300, may be slidably receiving within holes 412, 414of adapter bar 400.

The use of alignment tool 600 in connection with the assemblage oftibial drill guide mount 200 and tibial drill guide 202 and the adapterbar 400 is similar to the use of alignment tool 300 described above. Forexample, once the assembly of tibial drill guide mount 200 and tibialdrill guide 202 are disposed within resected joint space 22, adapter bar400 is coupled to alignment tool 600 by aligning holes 412 and 414 thatare respectively defined by extensions 408 and 410 with alignment rods604 of alignment tool 600. Adapter bar 400 is slid along alignment rods604 until holes 416 of adapter bar align with holes 216 defined by body204 of tibial drill guide 200. As described above, dowel pins areinserted into holes 416-1 and 416-2 of adapter bar 400 and 216-1 and216-2 of tibial drill guide mount 200. With dowels disposed within holes216-1, 216-2, 416-1, and 416-2, tibial drill guide mount 200 is properlyaligned with alignment tool 600 in the medial lateral (e.g.,x-direction) and superior-inferior (e.g., y-direction) directions. Ascrew is inserted through hole 416-3 into threaded hole 216-3, whichsecures tibial drill guide mount 200 to adapter bar 400 and providesproper alignment in the anterior-posterior direction (e.g., thez-direction). The surgeon may make final adjustments to the heel andforefoot clamps 508 and 510 and then create the intramedullary channelas described above.

FIGS. 39-63 illustrate another embodiment of a system for performing asurgical procedure. Specifically, FIGS. 39-43 illustrate a tibial drillguide mount 700 sized and configured to receive the tibial drill guidecartridge 702 illustrated in FIGS. 44-47. Tibial drill guide mount 700may also receive other drill guide cartridges for use during otherstages of the surgical procedures. Like tibial drill guide mount 200,tibial drill guide 700 may be fabricated from a resilient polymermaterial of the type that is suitable for use in connection with stereolithography, selective laser sintering, or the like manufacturingequipment, e.g., a polyamide powder repaid prototype material issuitable for use in connection with selective laser sintering.

As shown in FIG. 39-43, tibial drill guide mount 700 has a somewhatrectangular body 704 having a front side 706, a rear side 708, top side710, bottom side 712, and a pair of opposed sides 714 and 716. Frontside 706 defines a recess 718 sized and configured to slidably receivetibial drill guide 702 therein. Recess 718 communicates with a recess720 (FIGS. 39 and 43) defined by bottom side 712 and a recess 722 (FIGS.39, 42, and 43) defined by top side 710 such that body 704 issubstantially hollow.

The respective inner surfaces 724, 726 of sides 714, 716 have differentgeometries that correspond with the cross-sectional geometry of tibialdrill guide cartridge 702 to ensure that tibial drill guide cartridge702 is properly inserted into recess 718. In the embodiment illustratedin FIGS. 39-43, side 716 includes first and second ledges 728, 730 thatinwardly extend into recess 718, and side 714 has an inwardly taperedupper region 732 and an inwardly extending ledge 734. One skilled in theart will understand that sides 714, 716 may include other features forensuring proper insertion of tibial drill cartridge 702 into recess 718.In some embodiments, sides 714, 716 may have the identical geometry andtibial drill guide cartridge may be reversibly inserted into recess 718.

Front side 706 defines one or more dowel holes 736-1, 736-2(collectively referred to as “dowel holes 736”) sized and configured toreceive a dowel pin 70 therein. One or more through holes 738-1, 738-2,738-3 (collectively referred to as “through holes 738”) extend throughfront side 706, which also defines a blind hole 740. Through holes 738are sized and configured to receive k-wires for pinning tibial drillguide mount to a patient's bone as described below.

Top side 710 of tibial drill guide mount 700 includes a pair of chamfers742 that are sized and configured to be mate against and reference theresected surfaces of the lower tibia 16 a (FIG. 8). Tibial drill guidemount 700 also includes a tibial engagement structure 744 and a talarengagement structure 746. Tibial engagement structure 744 extends fromtop side 710 and includes a substantially conformal engagement surface748. Talar engagement structure 746 extends from bottom side 712 andalso includes a substantially conformal engagement surface 750.

Tibial drill guide cartridge 702 has a substantially rectangularelongate body 754 that may be formed from a more substantial materialthan tibial drill guide mount 700 such as, for example, metals,ceramics, or the like. As best seen in FIGS. 44 and 45, the geometry ofsides 756, 758 is respectively complementary to the sides 714, 716 oftibial drill guide mount 700. For example, side 758 includes ledges 760and 762 that respectively correspond to ledges 728 and 730, and side 756includes a ledge 764 and an angled section 766, which respectivelycorrespond to ledge 734 and upper region 732 of tibial drill guide mount700.

Front side 768 of tibial drill guide cartridge 700 defines a blind hole770, which may be threaded for reasons described below. Tibial drillguide cartridge 702 defines a pair of holes 772 and 774 that extend frombottom surface 776 to top surface 778. Hole 772 may be a reamed holethat is sized and configured to receive a ball detent therein, and hole774 has an internal surface 780 that tapers from a larger diameter atbottom surface 776 to a smaller surface that is sized and configured toreceive a surgical tool, such as a drill and/or reamer. Top surface 778defines a pair of parallel slots 782-1, 782-2 (collectively referred toas “slots 782”) that extend from side 756 to side 758. As best seen inFIGS. 44 and 47, slots 782 are disposed equidistant from a central axisdefined by hole 774 to provide a visual key for a physician that wantscheck the alignment of hole 774 with a mechanical axis of a patient'stibia using fluoroscopy.

As illustrated in FIG. 48, a mounting plate 800 has a substantiallyrectangular body 802 that is fabricated from a material including, butnot limited to, metals, ceramics, or the like. Body 802 defines anaperture 804 the extends from front side 806 to back side 808 and has asimilar geometry of recess 718 of tibial drill guide mount 700 such thattibial drill guide cartridge 702 may be received therein. Body 802 alsodefines a pair of through holes 810-1, 810-2 (collectively referred toas “holes 810”) that are arranged on body 802 such that they correspondto holes 738 of tibial drill guide mount 700 and are sized andconfigured to receive a k-wire or pin therein.

A mounting base 812 extends from front side 806 of mounting plate 800and defines a hole 814 that extends from a first side 816 to a secondside 818. Mounting base 812 defines a notch 820 and one or more dowelpin holes 822-1, 822-2 (collectively referred to as “holes 822”) thatare aligned with holes 736 of tibial drill guide mount 700. Notch 820bisects hole 814. Mounting base 812 may also define one or more recesses824 that correspond to one or more protrusions 784 that extends fromfront side 706 of tibial drill guide mount 700. Recesses 824 andprotrusions 784 cooperate to ensure that mounting base 812 and tibialdrill guide mount 700 are properly aligned. One skilled in the art willunderstand that other geometric features may be implemented to ensureproper alignment between mounting base 812 and tibial drill guide mount700.

As illustrated in FIGS. 49-54, mounting plate 800 may be coupled totibial drill guide mount 700 using dowel pins 70, which are receivedthrough holes 822 and 734. Tibial drill guide cartridge 702 is receivedthrough aperture 804 and recess 718 as best seen in FIG. 51. FIGS. 53and 54 illustrate that when tibial drill guide cartridge 702 is properlyinserted into the assemblage of tibial drill guide mount 700 andmounting plate 800, hole 772 aligns with hole 828 defined by mountingplate 800, which may include a ball detent (not shown) disposed therein.Consequently, the ball detent is received within hole 772 to retaintibial drill guide cartridge 702 disposed within aperture 804 and recess718 such that hole 774 is disposed within recesses 754 and 756. A screwor other threaded object (not shown) can be inserted into threaded hole770 and then pulled to remove tibial drill guide cartridge 702 fromaperture 804 and recess 718 as illustrated in FIGS. 53 and 54.

Tibial drill guide mount 700, tibial drill guide 702, and mounting plate800 may be used in connection with alignment tool 300, adapter bar 400,foot holder assembly 500, and alignment tool 600 as described above.Additionally, tibial drill guide mount 700, tibial drill guide 702, andmounting plate 800 may also be used in conjunction with foot holderassembly 900 illustrated in FIGS. 55-60 as can tibial drill guide mount200 and tibial drill guide 202.

As shown in FIG. 55, foot holder assembly 900 includes a base plate 902that extends from a first end 904 to a second end 906. First and secondends 904, 906 each define a pocket 908 and a hole 910. Pocket 908 issized and configured to receive a drill bushing 912 having a cylindricalbody defining hole 914 that aligns with through hole 910. Accordingly,both first end 904 and second end 906 may support an ankle or forefootof a patient. Each pocket 908 includes a spring loaded detent 916communicatively coupled to it that include a finger receiving surface918 and is configured to slide relative to base plate 902 and securedrill bushing 912 within pocket 908. In some embodiments, drill bushingmay be threaded and configured to be coupled to base plate 902 withcomplementary threads disposed on an inner surface of holes 910.

Base plate 902 also includes a medial/lateral extension 920 that extendsin a substantially perpendicular direction from an approximate mid-pointbetween first end 904 and second end 906. Base plate 902 may also definea viewing opening 922 such that a surgeon may be able to view the bottomof a patient's foot when the foot is secured to foot holder assembly900.

One or more rods 924 extend from base plate 902 in a substantiallyperpendicular direction with respect to an upper foot holding surface926 (FIG. 56). Rods 924 may be secured to base plate 902 using screws orthrough other securing means as will be understood by one skilled in theart. A cap 928 is secured to an upper end of rods 924 and be secured torods 924 using screws or other fixation means.

A mounting member 930 has an elongate body 932 that defines a pair ofholes 934, 936 at one end 938 that slidably receive rods 924 such thatmounting member 930 may be slid along rods 924 in order to positiontibial drill guide mount 700 with respect to base plate 902. A springloaded button 940 is disposed at first end 938 of mounting member 930and is coupled to a locking mechanism (not shown) disposed withinmounting member 930 for locking mounting member 930 at a position alongrods 924.

One or more holes 942 are defined at the second end 944 of mountingmember 930 and correspond to holes 716 of drill guide mount 700 forcoupling drill guide mount 700 to foot holder assembly 900. Second end942 also defines a slot 946, as best seen in FIGS. 56 and 60, that issized and configured to receive an internally threaded rod 948 of apivoting arrangement 950, which includes a lower portion 952 that isreceived within slot 820 of mounting plate 800 and is cross-pinnedthrough hole 814. The cross-pinning of pivoting arrangement 950 maypivot about an axis defined by hole 814 and is configured to receive ansupport tightening knob 954. Bottom surface 956 (FIG. 60) of knob 954has an outer dimension that is greater than slot 946 and is configuredto engage mounting member 930 in order to secure the assemblage ofmounting plate 800 and tibial drill guide mount 700, which may includetibial drill cartridge 702.

In operation, tibial drill guide mount 700 is inserted into resectedjoint space 22. Mounting plate 800 is connected to tibial drill guidemount 700 using dowel pins 70 as best seen in FIGS. 49 and 50. Withpivoting arrangement 950 cross-pinned to mounting plate 800, theassemblage of mounting plate 800 and pivoting arrangement 948 is coupledto tibial drill guide mount with dowel pins 70, which may be press fitinto holes 822 of mounting plate 800 and holes 716 of tibial drill guidemount 700 as will be understood by one skilled in the art. Tibial drillguide mount 700 and mounting plate may be secured within resected jointspace 22 by inserting k-wires (not shown) into holes 736, 790 defined bytibial drill guide mount 700 and holes 830-1, 830-2 (corresponding toholes 736-1, 736-2) and 832-1, 832-2 defined by mounting plate 800.

With mounting plate 800 coupled to tibial drill guide mount 700 that isdisposed within resected joint space 22, pivoting arrangement 948 isrotated such that it extends in a direction approximately parallel to alongitudinal axis defined by a patient's leg and the cartridge-styletibial drill guide 702 is inserted into aperture 804 of mounting plate800 and recess 718 of tibial drill guide mount 700. Tibial drill guidecartridge 702 is inserted until leading end 786 of tibial drillcartridge 702 abuts rear wall 788 of tibial drill guide mount 700 atwhich point the ball detent disposed within hole 772 engages hole 828defined by mounting plate 800 and the front side 768 of tibial drillguide cartridge 702 is flush with front side 806 of mounting plate 800.

Holes 940 of mounting member 930 are aligned with, and received over,dowel pins 70 that extend from front side 806 of mounting plate tocouple mounting member 930 of foot holder assembly 900 to the assemblageof mounting plate 800, tibial drill guide mount 700, and tibial drillguide cartridge 702. With mounting member 903 coupled to dowel pins 70and mounting plate 800, pivoting arrangement 948 is rotated with respectto mounting plate 800 such that rod 946 of pivoting arrangement 948 isreceived within slot 944 of mounting member 930. Knob 952 is thenrotated about its axis (clockwise or counterclockwise) such that thebottom surface 954 of knob 952 contacts mounting member 930 to maintainengagement between mounting member 930 and the assemblage of tibialdrill guide mount 700 and mounting plate 800.

Drill bushing 912 is coupled to hole 910 that is aligned with the heelof a patient's foot. As described above, drill bushing 912 may be slidinto pocket 908 defined by bottom plate 902 until spring loaded detents916 releasably lock drill bushing 912 in place. In some embodiments,drill bushing 912 may be screwed into base plate 902 by way ofcorresponding threads disposed on an outer surface of drill bushing 912that engage threads defined by an inner surface of pocket 908 and/orhole 910. With drill bushing 912 in place and the patient's leg securedto foot holder assembly 900, various minimally invasive surgicaltechniques may be used to introduce a bottom foot cannula into thecalcaneus 20, talus 14, and tibia 16 as described above.

Once access to the patent's calcaneus has been achieved, a bottom footcannula 64 is inserted through the patient's calcaneus 20. A reamer 66is operated through the cannula 64 to drill approximately anotherthrough the talus 14 and up into the tibia 16 to establish anintramedullary guide path through the calcaneus 20 and talus 14 leadinginto the tibia 16. As reamer 66 exits talus 14, the conically shapedinternal surface 748 guides the tip 68 into hole 788. An axis defined byhole 788 is substantially axially aligned with a mechanical axis oftibia 16 such that as reamer 66 is extended through hole 788, it boresan intramedullary canal within tibia 16.

The disclosed system and method advantageously utilize custommanufactured surgical instruments, guides, and/or fixtures that arebased upon a patient's anatomy to reduce the use of fluoroscopy during asurgical procedure. In some instances, the use of fluoroscopy during asurgical procedure may be eliminated altogether. The custom instruments,guides, and/or fixtures are created by imaging a patient's anatomy witha computer tomography scanner (“CT”), a magnetic resonance imagingmachine (“MRI”), or like medical imaging technology prior to surgery andutilizing these images to create patient-specific instruments, guides,and/or fixtures.

Although the invention has been described in terms of exemplaryembodiments, it is not limited thereto. Rather, the appended claimsshould be construed broadly, to include other variants and embodimentsof the invention, which may be made by those skilled in the art withoutdeparting from the scope and range of equivalents of the invention.

1. A system for establishing an intramedullary path, comprising: a bodysized and configured to be received within a resected bone space anddefining a first aperture that extends through the body, the firstaperture sized and configured to receive a surgical tool therethrough;and a first bone engaging structure extending from the body in a firstdirection, the first bone engaging structure including a first surfacethat is complementary to a surface topography of a first bone, whereinwhen the first surface of the bone engaging structure engages thesurface topography of the first bone to which the first surface iscomplementary, an axis defined by the first aperture is substantiallycollinear with a mechanical axis of the first bone.
 2. The system ofclaim 1, wherein the first bone is a tibia.
 3. The system of claim 1,wherein a second bone engaging structure extends from the body in adirection that is substantially opposite the first direction, the secondbone engaging structure including a second surface that is complementaryto a surface topography of a second bone.
 4. The system of claim 3,wherein the second bone is a talus.
 5. The system of claim 1, furthercomprising: a drill guide sized and configured to be received within thefirst aperture defined by the body, the drill guide defining a secondaperture sized and configured to receive the surgical tool therethrough.6. The system of claim 5, wherein the first aperture includes a reduceddiameter portion, and an outer surface of the drill guide includes afirst portion having a smaller cross-sectional area than a secondportion and being sized and configured to be received within the reduceddiameter portion of the first aperture.
 7. The system of claim 5,wherein an outer surface of the drill guide includes a flat surface thatis complementary to a non-rotation feature disposed within the firstaperture.
 8. The system of claim 5, wherein the second aperture tapersalong at least part of its length.
 9. The system of claim 1, wherein thebody defines at least one hole for coupling the body to a coupling bar,the coupling body configured to engage a pair of alignment rodsextending from a foot holder assembly.
 10. A system for establishing anintramedullary path, comprising: a drill guide mount including a bodysized and configured to be received within a resected bone space, thebody defining a first aperture that extends through the body, a firstbone engaging structure extending from the body in a first direction andincluding a first surface that is complementary to a surface topographyof a first bone; and a drill guide sized and configured to be receivedwithin the first aperture defined by the body of the drill guide mount,the drill guide defining a second aperture sized and configured toreceive the surgical tool therethrough, wherein when the first surfaceof the bone engaging structure engages the surface topography of thefirst bone to which the first surface is complementary, an axis definedby the first aperture is substantially collinear with a mechanical axisof the first bone.
 11. The system of claim 10, wherein a second boneengaging structure extends from the body of the drill guide mount in adirection that is substantially opposite the first direction, the secondbone engaging structure including a second surface that is complementaryto a surface topography of a second bone.
 12. The system of claim 11,wherein the first and second bone engaging structures each include atleast one hole sized and configured to receive a k-wire therethrough.13. The system of claim 10, wherein the first aperture includes areduced diameter portion, and an outer surface of the drill guideincludes a first portion having a smaller cross-sectional area than asecond portion and being sized and configured to be received within thereduced diameter portion of the first aperture.
 14. The system of claim10, wherein an outer surface of the drill guide includes a flat surfacethat is complementary to a non-rotation feature disposed within thefirst aperture.
 15. The system of claim 10, wherein the second aperturetapers along at least part of its length.
 16. The system of claim 10,further comprising a coupling bar sized and configured to engage a pairof alignment rods extending from a foot holder assembly, the couplingbar configured to be coupled to the body of the drill guide mount formaintaining a position of the drill guide mount relative to the footholder assembly.
 17. A method comprising: inserting a drill guide intoan aperture defined by a drill guide mount, the drill guide mountincluding a first bone engaging structure extending from a body of thedrill guide mount in a first direction and having a first surface thatis complementary to a surface topography of a first bone; inserting thedrill guide mount and the drill guide disposed within the first apertureof the drill guide mount into a resected bone space such that the firstsurface of the bone engaging structure correspondingly engages the firstbone; and extending a surgical tool through a second aperture defined bythe drill guide to establish an intramedullary channel within the firstbone that is substantially collinear with a mechanical axis of the firstbone.
 18. The method of claim 17, wherein the drill guide mount includesa second bone engaging structure that extends from the body of the drillguide mount in a direction that is substantially opposite the firstdirection, the second bone engaging structure including a second surfacethat is complementary to a surface topography of a second bone.
 19. Themethod of claim 18, wherein when the first surface of the bone engagingstructure correspondingly engages the first bone, the second surfacecorrespondingly engages the second bone.
 20. The method of claim 17,further comprising: inserting a first k-wire through a first holedefined by the first bone engaging structure and into the first bone;and inserting a second k-wire through a second hole defined by thesecond bone engaging structure and into the second bone.
 21. The methodof claim 17, further comprising: coupling the drill guide mount to acoupling bar; and attaching the coupling bar to a pair of alignment rodsextending from a surgical fixation assembly.
 22. The method of claim 21,wherein the surgical fixation assembly is a foot holder assembly, thefirst bone is the tibia, and the second bone is the talus.